Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial

Trials

Jan Vesper¹  Mohammad Mehdi Hajiabadi²  Benito Campos²  Andreas Unterberg²  Rezvan Ahmadi²  Dirk Rasche³  Volker Tronnier³  Tom Bruckner⁴  Colette Doerr-Harim⁵  Solveig Tenckhoff⁵ 

[1] Department of Functional Neurosurgery and Stereotaxy, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany;Department of Neurosurgery, University Hospital Heidelberg, INF 400, 69120, Heidelberg, Germany;Department of Neurosurgery, University of Lübeck, Lübeck, Germany;Institute of Medical Bioinformatics, University of Heidelberg, Heidelberg, Germany;The Study Center of the German Surgical Society (SDGC), University Hospital Heidelberg, Heidelberg, Germany;

关键词: Spinal cord stimulation;    Neuropathic pain;    Wireless stimulation;    Randomized controlled trial;   

DOI  :  10.1186/s13063-020-05013-7

来源: Springer

【 摘 要 】

BackgroundSpinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown which of the many available SCS modalities is most effective. Specifically, electrodes leading out through the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks or even months. The risk of wound infections for such a study would be unacceptably high and blinding of the trial difficult. The PARS-trial seizes the capacity of a new type of wireless SCS device, which enables a blinded and systematic intra-patient comparison of different SCS modalities over extended time periods and without increasing wound infection rates.MethodsThe PARS-trial is designed as a double-blinded, randomized, and placebo-controlled multi-center crossover study. It will compare the clinical effectiveness of the three most relevant SCS paradigms in individual patients. The trial will recruit 60 patients suffering from intractable neuropathic pain of the lower extremities, who have been considered for SCS therapy and were already implanted with a wireless SCS device prior to study participation. Over a time period of 35 days, patients will be treated consecutively with three different SCS paradigms (“burst,” “1 kHz,” and “1.499 kHz”) and placebo stimulation. Each SCS paradigm will be applied for 5 days with a washout period of 70 h between stimulation cycles. The primary endpoint of the study is the level of pain self-assessment on the visual analogue scale after 5 days of SCS.Secondary, exploratory endpoints include self-assessment of pain quality (as determined by painDETECT questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale), and physical restriction (as determined by the Oswestry Disability Index).DiscussionCombining paresthesia-free SCS modalities with wireless SCS offers a unique opportunity for a blinded and systematic comparison of different SCS modalities in individual patients. This trial will advance our understanding of the clinical effectiveness of the most relevant SCS paradigms.Trial registrationGerman Clinical Trials Register, DRKS00018929. Registered on 14 January 2020.

【 授权许可】

CC BY